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Safe Administration of Intrathecal Cytotoxic Chemotherapy
Safe Administration of Intrathecal Cytotoxic Chemotherapy
Safe Administration of Intrathecal Cytotoxic Chemotherapy
Standards and Guidelines Comm. - Safe Administration of Intrathecal Chemotherapy – V1– May 2011
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Version Record
Policy Record
Date Version
Author (s) Approval
Director Responsible Approval
Standards and Guidelines Comm. - Safe Administration of Intrathecal Chemotherapy – V1– May 2011
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Full Description
2. Introduction:
In 2008 the National Patient Safety Agency (NPSA) and the UK Department of
Health (DoH) reported fatal and serious incidents from hospitals in which doses of
vinca alkaloids intended for intravenous administration have been administered by
the intrathecal (spinal) route in error.
3. Purpose:
To comply with national guidance on the Safe Administration of Intrathecal
Chemotherapy - HSC 2008/001 and the NPSA/2008/RRR004.
4. The scope:
This policy applies to staff involved in one or more of the following tasks: the
dispensing, issuing, prescribing, checking and administering of intrathecal cytotoxic
chemotherapy - in the adolescent and adult haematology services at Belfast City
Hospital (BCH) and Royal Belfast Hospital for Sick Children (RBHSC).
5. Objectives:
To describe the policy for the following facets of intrathecal cytotoxic chemotherapy
administration:
Induction and training
Registration of designated trained personnel
Prescribing
Preparation, dispensing, issuing, storage and issue
Checking and administration
Protocol violation
Dr Macartney and Dr Cuthbert take direct responsibility for these activities for
medical staff.
The following lead trainers have delegated responsibility within their disciplines:
Maurice Regan for pharmacy staff (BCH)
Anne Simpson for pharmacy staff (RBHSC)
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Formal induction programmes and annual review of staff competence are conducted
in the three disciplines, and written confirmation of staff competence is recorded for
the relevant designated task(s).
The UK Department of Health agreed a target to reduce the number of patients dying
or being paralysed by maladministered spinal injections to zero by the end of 2001
and National Guidance was issued in 2001 (HSC 2001/022) to support this. The
guidance was updated in 2003 (HSC 2003/010), and in August 2008 (HSC
2008/001).
Personnel on the register are the only members of staff authorised to participate in
tasks related to intrathecal chemotherapy.
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8.3.2 Health care staff not involved in providing the intrathecal chemotherapy service, but
working in areas where it is undertaken, must not take part or be asked to take part
in any part of this process.
8.3.3 Medical staff must not prescribe or administer intrathecal chemotherapy until
completion of appropriate induction and training, and have had their competency
assessed and documented.
The supervising doctor must take ultimate responsibility for the patient assessment,
drug checking and administration procedures, but should ensure that the trainee is
undertaking these procedures correctly.
8.3.4 Nursing and pharmacy staff are provided with induction and training programme
appropriate to their role in the safe handling, dispensing, storage, and checking of
intrathecal cytotoxic drugs.
When individuals have completed their training and assessment they are given a
certificate of competency, and their names are added to the register of personnel
designated to participate in tasks related to intrathecal chemotherapy. They must
sign a written confirmation that they have read and understood this policy. This
training and assessment should be updated annually as annual refresher training is
required to remain on the register.
8.4 Prescribing:
8.4.1 Only those designated consultants, associate specialists, SpR’s and grades ST3 and
above whose names appear on the register are authorised to prescribe intrathecal
chemotherapy.
Staff grades, SHO’s, FT1, FT2, ST1, & ST2 doctors are not authorised to prescribe
intrathecal chemotherapy.
The chart includes the drug name, dose, route of administration and signatures of
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They must be packed and transported separately from drugs administered by other
routes.
8.5.2 Labels added in pharmacy should have the route of administration printed clearly in
the largest font size possible and emboldened:
8.5.3 Intrathecal cytotoxic drugs must be stored in each of the Satellite Pharmacies in a
dedicated, locked container kept in the refrigerator, or in the locked refrigerator
reserved for intrathecal chemotherapy on Ward 10 North (BCH) or
Haematology/Oncology outpatient area (RBHSC).
Intrathecal cytotoxic drugs must be issued from Satellite Pharmacy directly to the
doctor carrying out the intrathecal procedure, or taken to the ward by a designated
member of the pharmacy staff. Intrathecal therapy delivered to the ward must be
either issued directly to the doctor carrying out the intrathecal procedure or placed in
the designated refrigerator.
In both instances the pharmacy staff member must sign the release of the drugs and
record to whom they were released or record placement in the designated
refrigerator. Only the doctor who is to administer the intrathecal cytotoxic drugs may
remove them from the refrigerator, and must then check them.
N.B. Liposomal cytarabine for intrathecal use (Depocyte) must be stored at room
temperature. Therefore, the doctor carrying out the intrathecal administration must
collect it directly from pharmacy just before the procedure, and it must not be stored
in the designated ward refrigerator.
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RBHSC
In RBHSC intrathecal chemotherapy is delivered under general anaesthesia.
Therefore in RBHSC only, the intrathecal chemotherapy will be administered first,
and the intravenous chemotherapy will only be issued after the pharmacy staff have
received written confirmation that the intrathecal chemotherapy has been
administered.
8.6.3 The administering doctor must review the patient clinically to ensure that he/she is fit
for treatment, the correct tests have been done, and the correct chemotherapy has
been prescribed. Confirmation that the review has taken place must be written in the
patient’s medical notes.
8.6.4 The doctor must use a formal checking procedure before administration of intrathecal
chemotherapy. This includes checking the:-
drug name,
drug dosage,
date of expiry,
date to be administered,
route of administration,
patient’s name and
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As part of the review, the member of staff should check that any staff assisting in the
procedure are on the register for the task they are carrying out.
8.6.6 At the end of the procedure the prescription sheet completed with the appropriate
signatures must be returned to pharmacy for registration **, before ultimately being
filed in the patient’s notes. (**Filed directly in patients notes in RBHSC).
8.6.7 The patient, or a relative or guardian, should be given the opportunity to participate in
the checking procedure if they so wish. In any case the patient’s identity must be
confirmed, and purpose of the procedure, its method of conduct, and details of the
drug being administered must be explained to the patient and/or guardian. Signed
consent must be obtained before proceeding.
Any protocol violations or near misses should be reported as clinical incidents on the
Trust’s Incident Report Form, and the designated lead clinicians (CAM or RJGC)
must be informed.
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3. For patients >10yrs with poor veins and where peripheral administration of larger
volumes of vinca alkaloids poses an increased risk of extravasation injury, then
the consultant haematologist/oncologist can request in writing that these doses
are presented in their undiluted form. This is local practice and not taken from the
national policy document.
4. Intravenous vinca alkaloids are not routinely administered on the same day for
the same patient as intrathecal chemotherapy at RBHSC. However in rare
circumstances it may be necessary to administer a vinca alkaloid on the same
day as intrathecal chemotherapy. In this case the signed intrathecal prescription
chart will be used as confirmation that the intrathecal procedure has been
completed prior to the intravenous vinca alkaloid being released from pharmacy.
The vinca alkaloid must only be administered in either the Haematology
Outpatient area or ward.
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Procedures:
This policy should be read in conjunction with:
Appendix 1 = BCH protocol for designated medical staff involved in prescribing and
administering intrathecal chemotherapy. (2008)
Appendix 2 = BCH protocol for designated nursing staff involved in checking intrathecal
chemotherapy prior to its administration (2008)
Appendix 3 = RBHSC protocol for designated nursing staff involved in checking intrathecal
chemotherapy prior to its administration (2008)
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Appendix 1
Contraindications:
Raised intracranial pressure
Local sepsis at injection site
Allergy to the intrathecal drug
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Single agent, double and triple therapy protocols are available. For intrathecal
use, preservative-free formulations of these drugs are dispensed by pharmacy,
as preservatives can cause arachnoiditis.
Side effects:
CSF leak and lumbar puncture headache
Sepsis
Methotrexate-induced neurotoxicity: Chemical arachnoiditis
Seizures
Leucoencephalopathy
Systemic methotrexate effect - prolongation of cytopenias. Consider
folinic acid rescue.
Patient Assessment:
Confirm the identity of the patient by asking their name, DOB and
address, and check the hospital number on his/her wrist band.
Examine the patient to exclude raised intracranial pressure and to ensure
that he/she is otherwise fit for lumbar puncture.
Check relevant blood counts. If the platelet count is less than 50 x 109/L
platelets should be given before proceeding.
Explain the nature of the procedure, the drug(s) and method of
administration to the patient and relative/guardian.
Obtain signed, informed consent.
Check the drugs, dosage, expiry, and patient identification against the
prescription.
A cross check must be done independently by a designated haematology
nurse whose name appears on the current register of personnel
authorised to check intrathecal chemotherapy.
If a designated nurse is not available postpone the procedure
The cross check must not be done by another doctor.
The patient or a relative/guardian may wish to see the prescription and
the syringe labelling.
Administration:
Proceed with a standard lumbar puncture at L3/4 or standard Omaya
reservoir access.
Lidocaine 1% must be used as the local anaesthetic.
Collect 2-5 ml CSF for cytospin and routine microbiology.
Administer intrathecal cytotoxic drug(s) by slow intrathecal push.
Remove the needle and cover the puncture site with a sterile dressing.
After the procedure is complete allow the patient to mobilise cautiously.
There is no evidence that prolonged supine posture reduces the risk of
lumbar puncture headache.
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Documentation:
The doctor administering the drug(s) must receive them directly from a
designated pharmacist in Satellite Pharmacy, or from the designated
refrigerator on Ward 10 North. In both situations the prescription sheet
must be signed to indicate that the doctor has received the drug(s).
For outpatients the drugs must be collected directly from Satellite
Pharmacy.
The intrathecal drugs must remain in your possession until administered,
or locked in the designated refrigerator on Ward 10 North.
The administering doctor and the designated nurse who checks the drugs
against the prescription must sign the prescription sheet in the appropriate
sections.
After the procedure send the completed prescription sheet back to
pharmacy for registration. It will then be filed in the patient’s note.
Protocol Violation:
All staff involved with the care of patients receiving cytotoxic chemotherapy
including intrathecal chemotherapy are encouraged to challenge non-adherence
to protocols or individual actions which incur potential risk to patients. Such
challenges should not be perceived as adversarial, but rather as an additional
check to maintain patient safety. Individuals who are so challenged must accept
that a discussion is required to investigate the issue in the interests of patient
safety. Any protocol violations or near misses should be reported as clinical
incidents on the Trust’s incident report form (IR Clinical), and the designated lead
clinician (RJGC) must be informed.
RJG Cuthbert
Updated to comply with HSC/2008/001 – August 2008
1
From 06 October 2008 vinca alkaloids will be administered only in 50ml of 0.9% sodium chloride
by minibag iv infusion over 5-10 minutes.
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Appendix 2
Nurse’s role: The haematology nurse plays an important role in patient care
during the administration of intrathecal chemotherapy. The nurse should consider
the patient holistically, mindful that he/she will require information, support and
reassurance. A critical component of patient safety is the key role the nurse plays
in checking that the correct drug and dosage are administered. Only those nurses
on the intrathecal chemotherapy register must be involved in the checking
process. If the nurse does not have a certificate and his/her name is not on the
live intrathecal register he/she must not be involved in any aspect of intrathecal
cytotoxic chemotherapy.
Contraindications:
Raised intracranial pressure
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Single agent, double and triple therapy protocols are available. For intrathecal
use, preservative-free formulations of these drugs are dispensed by pharmacy,
as preservatives can cause arachnoiditis.
Side effects:
Cerebrospinal fluid (CSF) leak and lumbar puncture headache
Sepsis
Methotrexate-induced neurotoxicity: Chemical arachnoiditis
Seizures
Leucoencephalopathy
Systemic methotrexate effect - prolongation of cytopenias and stomatitis.
Consider folinic acid rescue.
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Carry out the cross check which must be done independently by the
designated haematology nurse whose name appears on the current
register of personnel authorised to check intrathecal chemotherapy and
the administering doctor.
If a designated nurse is not available the procedure must be postponed
The cross check must not be done by another doctor.
Facilitate the patient or a relative/guardian to see the prescription and the
syringe labelling if they so wish, or verbally ascertain that they are aware
that intrathecal chemotherapy is to be given during the lumbar puncture
The nurse must remain present for the entire process of the intrathecal
chemotherapy administration
If the prescribed intrathecal chemotherapy is for any reason not
successfully administered, the patient’s consultant and Dr Cuthbert should
be informed.
Administration:
Assist the patient into a comfortable foetal position
Assist with a standard lumbar puncture at L3/4 or standard Omaya
reservoir access.
Ensure Lidocaine 1% is used as the local anaesthetic.
Assist the doctor to collect 2-5 ml CSF for cytospin and routine
microbiology.
Remain present during the administration of the intrathecal cytotoxic
drug(s) by slow intrathecal push and reassure the patient.
Provide a sterile dressing to cover the puncture site with.
After the procedure is complete allow the patient to mobilise cautiously.
There is no evidence that prolonged supine posture reduces the risk of
lumbar puncture headache.
Check the puncture site dressing for any signs of haemorrhage or CSF
leak post procedure
Monitor the patient’s observations, as a minimum pre procedure and once
post procedure, or as dictated by the clinical condition of the patient and
in particular the respiration rate, if the patient has received sedation
during the procedure
In the day care context, if the procedure is performed without
complication, the patient should be allowed home within 30-60minutes,
depending on ascertaining that he/she is safely ambulant.
Ensure the puncture site is checked and the dressing removed 24 hours
post procedure
2
From 06 October 2008 vinca alkaloids will be administered only in 50ml of 0.9% sodium chloride
by minibag iv infusion over 5-10 minutes.
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Protocol Violation:
All staff involved with the care of patients receiving cytotoxic chemotherapy
including intrathecal chemotherapy are encouraged to challenge non-adherence
to protocols or individual actions which incur potential risk to patients. Such
challenges should not be perceived as adversarial, but rather as an additional
check to maintain patient safety. Individuals who are so challenged must accept
that a discussion is required to investigate the issue in the interests of patient
safety. Any protocol violations or near misses should be reported as clinical
incidents on the Trust’s incident report form (IR Clinical), and the designated lead
clinician (RJGC) must be informed.
RJG Cuthbert
Updated to comply with HSC/2008/001 – August 2008
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Appendix 3
Nurse’s role: The haematology nurse plays an important role in patient care
during the administration of intrathecal chemotherapy. The nurse should consider
the patient holistically, mindful that he/she will require information, support and
reassurance. A critical component of patient safety is the key role the nurse plays
in checking that the correct drug and dosage are administered. Only those nurses
on the intrathecal chemotherapy register must be involved in the checking
process. If the nurse does not have a certificate and his/her name is not on the
live intrathecal register he/she must not be involved in any aspect of intrathecal
cytotoxic chemotherapy.
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Contraindications:
Raised intracranial pressure
Local sepsis at injection site
Allergy to the intrathecal drug
Side effects:
Cerebrospinal fluid (CSF) leak and lumbar puncture headache
Sepsis
Methotrexate-induced neurotoxicity: Chemical arachnoiditis
Seizures
Leucoencephalopathy
Systemic methotrexate effect - prolongation of cytopenias and stomatitis.
Consider folinic acid rescue.
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Administration:
Most children will have this performed under general anaesthesia
Assist the patient into a comfortable foetal position
Assist with a standard lumbar puncture at L3/4 or standard Omaya
reservoir access.
Assist the doctor to collect 10-15 drops of CSF for cytospin, and routine
microbiology if indicated.
Remain present during the administration of the intrathecal cytotoxic
drug(s) by slow intrathecal push.
Provide a sterile dressing to cover the puncture site with.
After the procedure is complete the patient will be transferred to recover
from the general anaesthetic.
Check the puncture site dressing for any signs of haemorrhage or CSF
leak post procedure
Monitor the patient’s observations, particularly the respiration rate, if the
patient has received sedation during the procedure.
Ensure the puncture site is checked and the dressing removed 24 hours
post procedure
3
From 06 October 2008 vinca alkaloids will be administered only in 50ml of 0.9% sodium chloride
by minibag iv infusion over 5-10 minutes.
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Documentation:
The doctor administering the drug(s) must receive them directly from a
designated pharmacist in Satellite Pharmacy, or from the designated
refrigerator in the haematology/oncology outpatient area. In both
situations the prescription sheet must be signed to indicate that the doctor
has received the drug(s).
The intrathecal drugs must remain in the administering doctor’s
possession until administered, or locked in the designated refrigerator in
the haematology/oncology outpatient area.
The administering doctor and the designated nurse who checks the drugs
against the prescription must sign the prescription sheet in the appropriate
sections.
After the procedure the completed prescription sheet should be filed in the
patient’s notes.
Document the procedure in the medical and nursing notes
Protocol Violation:
All staff involved with the care of patients receiving cytotoxic chemotherapy
including intrathecal chemotherapy are encouraged to challenge non-adherence
to protocols or individual actions which incur potential risk to patients. Such
challenges should not be perceived as adversarial, but rather as an additional
check to maintain patient safety. Individuals who are so challenged must accept
that a discussion is required to investigate the issue in the interests of patient
safety. Any protocol violations or near misses should be reported as clinical
incidents on the Trust’s incident report form (IR Clinical), and the designated lead
clinician (C Macartney) must be informed.
CA Macartney
Updated to comply with HSC/2008/001 – August 2008
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Appendix 4
General
1. Intrathecal chemotherapy is managed in accordance with the updated
National Guidance on the Safe Administration of Intrathecal Chemotherapy
(HSC 2008/001), the recommendations of the National Patient Safety
Agency regarding the presentation of intravenous vinca alkaloids
(NPSA/2008/RRR004), and the Belfast Trust Policy.
2. This Policy must be read in conjunction with the updated national guidance,
the NPSA recommendations and the Belfast Trust Policy.
Registers
1. An up-to-date copy of the register of designated personnel who have been
trained and certified competent in the prescribing, dispensing, issuing,
checking (prior to administration) and administering of intrathecal
chemotherapy is held in the Satellite Pharmacy. An electronic version is
available at
http://hpssweb.n-i.nhs.uk/niccpharmacy/index.html
3. A copy of the Trust’s waiver to the national policy (if applicable), signed by
the Chief Executive, the Medical Director, the Nurse Director and the Chief
Pharmacist, allowing competent ST1 and ST2 grades to be registered to
administer intrathecal chemotherapy, must be held in the Satellite
Pharmacy.
Training
1. Staff must be provided with formal induction training appropriate to their role
in the intrathecal chemotherapy service.
2. The induction training must cover all of the potential clinical hazards
associated with intrathecal chemotherapy, the danger posed to patients if
vinca alkaloids are accidentally administered intrathecally, and the NPSA
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3. Trainers must ensure that it is made clear to staff that they should challenge
colleagues if they believe that protocols are not being adhered to or if the
actions of an individual may cause risk to a patient receiving intrathecal
chemotherapy.
6. Staff must be given written confirmation (e.g. a certificate) that they have
completed training / annual refresher training and are competent / remain
competent to be included on the register for the designated task.
Prescribing
1. Intrathecal chemotherapy may only be prescribed by members of staff who
have been designated, trained, certified competent and registered to
prescribe intrathecal chemotherapy by the hospital.
Administering
1. Intrathecal chemotherapy may only be administered by members of staff
who have been designated, trained, certified competent and registered to
administer intrathecal chemotherapy by the hospital.
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Dispensing
1. Intrathecal chemotherapy may only be dispensed by members of staff who
have been designated, trained, certified competent and registered to
dispense intrathecal chemotherapy by the hospital.
Issuing
1. Intrathecal chemotherapy may only be issued by members of staff who have
been designated, trained, certified competent and registered to issue
intrathecal chemotherapy by the hospital.
2. Intrathecal drugs must only be issued when written proof has been provided
that all intravenous drugs (for that patient that day) have been administered.
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6. The issuer must sign the intrathecal chemotherapy prescription chart and
record the identity of the administering doctor.
8. A registered member of pharmacy staff (the issuer) may take the intrathecal
chemotherapy directly to the ward. In the absence of the administering
doctor, the issuer may place the intrathecal chemotherapy in a designated,
dedicated, lockable container/refrigerator. The container / refrigerator must
be locked at all times and the key kept by the member of staff-in-charge of
the ward. In this case the issuer must sign the intrathecal chemotherapy
prescription chart and identify that the drugs have been lodged in the
relevant container/refrigerator. Only the registered administering doctor may
collect the intrathecal drugs from the container/ refrigerator when they must
check the drugs and sign for their collection.
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Appendix 5
Prepared by:- Barbara Jackson Approved by:- Nan Simpson Reviewed by:-
Date:- 01/10/10 Date:- 28/02/11 Date:-
Review Date: 01/02/2012
Background
Since 1985 at least 13 patients have died or been paralysed as a result of the accidental
intrathecal administration of Vinca alkaloids which was intended for intravenous
administration.
A register of designated personnel who have undergone training and been certified
competent in the prescribing, dispensing, issuing, checking and administering of
intrathecal chemotherapy must be maintained by the Trust and up-to-date copies of this
should be kept at all relevant locations. The register is also held electronically on the NI
Cancer Centre pharmacy website:
http://hpssweb.n-i.nhs.uk/niccpharmacy/index.html
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Training
4. The Trainer and Trainee must sign the Intrathecal Chemotherapy Training and
Assessment Form.
6. Training must be repeated (*) at least every year. This refresher training must be
documented.
7. In the event that a Pharmacist or Technician works infrequently in the unit then
the pharmacy policy/procedures should be read each time intrathecal
chemotherapy is prepared.
Only those members of staff who have received training, are deemed competent
and whose name appear on the Intrathecal Register may undertake any duties
relating to intrathecal chemotherapy.
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3. Only pharmacy staff whose name appear on the current IT register may clinically
check, dispense, release and deliver intrathecal chemotherapy.
4. The Pharmacist must follow the SOP for checking a chemotherapy prescription
and must sign the IT prescription.
5. A worksheet must be completed as per SOP for each intrathecal dose for each
patient.
10. The Pharmacist checking and releasing the intrathecal chemotherapy must sign
the IT prescription.
11. Intrathecal chemotherapy must be delivered separately from all other treatments
and stored in the designated IT fridge in the Haematology Clinic. This is a
lockable fridge reserved for this purpose alone. No other drugs can be stored in
this fridge.
12. The authorised member of pharmacy staff delivering the drugs must sign that
they have delivered the drugs to the administering doctor or sign that they have
placed them in the designated IT fridge in the Haematology Clinic.
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5. In 2008 the National Patient Safety Agency issued a report regarding the
presentation of intravenous vinca alkaloids (NPSA/2008/RRR004). This report
supported the use of minibags in adult and adolescent units. It was
acknowledged that in paediatric units, vinca alkaloid doses could continue to be
presented in a syringe ie. no change to current practice.
8. For patients >10yrs with poor veins and where peripheral administration of larger
volumes of vinca alkaloids poses an increased risk of extravasation injury, then
the consultant haematologist/oncologist can request in writing that these doses
are presented in their undiluted form. This is local practice rather and not taken
from the national policy document.
9. Intravenous vinca alkaloids are not routinely administered on the same day for
the same patient as intrathecal chemotherapy at RBHSC. However in rare
circumstances it may be necessary to administer a vinca alkaloid on the same
day as intrathecal chemotherapy. In this case the signed intrathecal prescription
chart will be used as confirmation that the intrathecal procedure has been
completed prior to the intravenous vinca alkaloid being released from pharmacy.
The vinca alkaloid must only be administered in either the Haematology
Outpatient area or ward.
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Appendix 6
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MARCH 2002 TPN/PROCEDURES/INTRAMETHOT02
Patient Name:
Hospital Number:
Date of Birth:
Protocol Name:
Prescribed by
Consultant/Specialist Date-
Registrar Signature
Checked by
Clinical Pharmacists Date
Signature
Checked and released by
Pharmacists Signature Date
Delivered by
Pharmacy Staff Member Date
Signature
* Received by
Consultant/Specialist Date
Registrar/Clinical Medical
Officer Signature
Pre-administration check
Consultant/Specialist Registrar/ Date
Clinical Medical Officer
Chemotherapy trained Nurse Signature
Administered by
Consultant/Specialist Date
Registrar/Clinical
Medical Officer Signature Time given
* This must be the Doctor who is administering the intrathecal drug. If this Doctor is unavailable please
sign below that the drug has been placed in the designated refrigerator for intrathecal drugs
Date
Standards and Guidelines Comm. - Safe Administration of Intrathecal Chemotherapy – V1– May 2011